Home NDC 63304-793 Simvastatin
Product NDC 63304-793
11-digit product format 633040793
Labeler code 63304
Product ID 63304-793_d005a31b-31ba-400e-a75c-99e6adf745bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name simvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc.
Application ANDA076285
Marketing category ANDA
Marketing start 2006-12-20
Marketing end 0000-00-00
Substance SIMVASTATIN
Active strength 80 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 114 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076285-001 SIMVASTATIN SIMVASTATIN 5MG TABLET / ORAL 2006-12-20 A076285-002 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL 2006-12-20 A076285-003 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL 2006-12-20 A076285-004 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL 2006-12-20 A076285-005 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL 2006-06-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 6 · 215 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A076285-001 SIMVASTATIN 5MG TABLET / ORAL 2006-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076285-002 SIMVASTATIN 10MG TABLET / ORAL 2006-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076285-003 SIMVASTATIN 20MG TABLET / ORAL 2006-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076285-004 SIMVASTATIN 40MG TABLET / ORAL 2006-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076285-005 SIMVASTATIN 80MG TABLET / ORAL 2006-06-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076285-001 SIMVASTATIN 5MG TABLET / ORAL 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076285-002 SIMVASTATIN 10MG TABLET / ORAL 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076285-003 SIMVASTATIN 20MG TABLET / ORAL 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076285-004 SIMVASTATIN 40MG TABLET / ORAL 2006-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076285-005 SIMVASTATIN 80MG TABLET / ORAL 2006-06-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076285-001 SIMVASTATIN 5MG TABLET / ORAL 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076285-002 SIMVASTATIN 10MG TABLET / ORAL 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076285-003 SIMVASTATIN 20MG TABLET / ORAL 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076285-004 SIMVASTATIN 40MG TABLET / ORAL 2006-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076285-005 SIMVASTATIN 80MG TABLET / ORAL 2006-06-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076285-001 SIMVASTATIN 5MG TABLET / ORAL 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076285-002 SIMVASTATIN 10MG TABLET / ORAL 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076285-003 SIMVASTATIN 20MG TABLET / ORAL 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076285-004 SIMVASTATIN 40MG TABLET / ORAL 2006-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076285-005 SIMVASTATIN 80MG TABLET / ORAL 2006-06-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076285-001 SIMVASTATIN 5MG TABLET / ORAL 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076285-002 SIMVASTATIN 10MG TABLET / ORAL 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076285-003 SIMVASTATIN 20MG TABLET / ORAL 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076285-004 SIMVASTATIN 40MG TABLET / ORAL 2006-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076285-005 SIMVASTATIN 80MG TABLET / ORAL 2006-06-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076285-001 SIMVASTATIN 5MG TABLET / ORAL 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076285-002 SIMVASTATIN 10MG TABLET / ORAL 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076285-003 SIMVASTATIN 20MG TABLET / ORAL 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076285-004 SIMVASTATIN 40MG TABLET / ORAL 2006-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076285-005 SIMVASTATIN 80MG TABLET / ORAL 2006-06-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076285-001 SIMVASTATIN 5MG TABLET / ORAL 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076285-002 SIMVASTATIN 10MG TABLET / ORAL 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076285-003 SIMVASTATIN 20MG TABLET / ORAL 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076285-004 SIMVASTATIN 40MG TABLET / ORAL 2006-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076285-005 SIMVASTATIN 80MG TABLET / ORAL 2006-06-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076285-001 SIMVASTATIN 5MG TABLET / ORAL 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076285-002 SIMVASTATIN 10MG TABLET / ORAL 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076285-003 SIMVASTATIN 20MG TABLET / ORAL 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076285-004 SIMVASTATIN 40MG TABLET / ORAL 2006-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076285-005 SIMVASTATIN 80MG TABLET / ORAL 2006-06-23 03ed91905a0d…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Related label table NDC Related label 63304-793-10 These highlights do not include all the information needed to use simvastatin tablets, USP safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin tablets, USP Initial U.S. Approval: 1991 63304-793-30 These highlights do not include all the information needed to use simvastatin tablets, USP safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin tablets, USP Initial U.S. Approval: 1991 63304-793-50 These highlights do not include all the information needed to use simvastatin tablets, USP safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin tablets, USP Initial U.S. Approval: 1991 63304-793-90 These highlights do not include all the information needed to use simvastatin tablets, USP safely and effectively. See full prescribing information for simvastatin tablets, USP. Simvastatin tablets, USP Initial U.S. Approval: 1991
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63304-793-10 Simvastatin 1000 in 1 BOTTLE TABLET, FILM COATED 1000 10 63304-793-30 Simvastatin 30 in 1 BOTTLE TABLET, FILM COATED 30 10 63304-793-50 Simvastatin 50 in 1 BOTTLE TABLET, FILM COATED 50 10 63304-793-90 Simvastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIMVASTATIN ACTIVE INGREDIENT AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 SIMVASTATIN ACTIVE MOIETY AGG2FN16EV SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-793 SIMVASTATIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 10 Legacy NDC, 4 package rows 20140429_cdb54447-86a5-4924-a7de-ec170f86651d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 63304-793-10 63304079310 1000 in 1 BOTTLE Historical 63304-793-30 63304079330 30 in 1 BOTTLE Historical 63304-793-50 63304079350 50 in 1 BOTTLE Historical 63304-793-90 63304079390 90 in 1 BOTTLE Historical